Sees Impact of Global Market Concerns;
Reiterates Encouraging Clinical Data
BETHESDA, MD / CRWEPRESSRELEASE / January 8, 2016 – Northwest Biotherapeutics (NASDAQ: NWBO) (“NW Bio”), a U.S. biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, today issued the following statement addressing the sharp decline in the Company’s stock:
Global markets are experiencing serious concerns, many biotech companies’ stocks have fallen dramatically, and NW Bio believes that its stock is being heavily impacted by these serious adverse market conditions. NW Bio is not aware of any fundamental Company-related reason for the substantial decline in the price of the Company’s stock at this time.
The most recent data from NW Bio’s clinical programs, which was presented at scientific conferences in London and New York in mid-September, was encouraging. The Company raised significant capital in Q4 2015, and is looking forward to being able to initiate its Phase 2 clinical trials with DCVax-Direct.
The Company’s September 2015 update included encouraging ongoing interim survival data from both the Phase I trial of DCVax-Direct in 13 diverse cancers, and the Information Arm of 51 patients who were unable to enroll in the Phase III trial of DCVax-L for newly diagnosed Glioblastoma multiforme (GBM) brain cancer because of apparent early tumor recurrence.
In the DCVax-Direct trial for patients with multiple inoperable metastatic tumors who had failed standard treatments (including multiple different chemotherapy regimens), half of these patients were still alive with survival times ranging up to 22 months, exceeding expected survival times.
In the DCVax-L Information Arm, for the 25 GBM patients with apparent early tumor recurrence at one of two time points, 40% of the patients had reached or exceeded approximately 3 years’ survival. This substantially exceeded the expected survival time of about 15 months even for regular GBM patients without early tumor recurrence.
About Northwest Biotherapeutics
Northwest Biotherapeutics is a biotechnology company focused on developing personalized immunotherapy products designed to treat cancers more effectively than current treatments, without toxicities of the kind associated with chemotherapies, and on a cost-effective basis, in both the United States and Europe. The Company has a broad platform technology for DCVax dendritic cell-based vaccines. The Company’s lead program is a 348-patient Phase III trial in newly diagnosed Glioblastoma multiforme (GBM), which is on a partial clinical hold in regard to new screening of patients. GBM is the most aggressive and lethal form of brain cancer, and is an “orphan disease.” The Company is under way with a 60-patient Phase I/II trial with DCVax-Direct for all types of inoperable solid tumors cancers. It has completed enrollment in the Phase I portion of the trial. The Company previously conducted a Phase I/II trial with DCVax-L for metastatic ovarian cancer together with the University of Pennsylvania. The Company previously received clearance from the FDA for a 612-patient Phase III trial in prostate cancer. In Germany, the Company has received approval of a 5-year Hospital Exemption for the treatment of all gliomas (primary brain cancers) outside the clinical trial.
Statements made in this news release that are not historical facts, including statements concerning future treatment of patients using DCVax and future clinical trials, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “expect,” “believe,” “intend,” “design,” “plan,” “continue,” “may,” “will,” “anticipate,” and similar expressions are intended to identify forward-looking statements. Actual results may differ materially from those projected in any forward-looking statement. Specifically, there are a number of important factors that could cause actual results to differ materially from those anticipated, such as risks related to the Company’s ongoing ability to raise additional capital, risks related to the Company’s ability to enroll patients in its clinical trials and complete the trials on a timely basis, uncertainties about the clinical trials process, uncertainties about the timely performance of third parties, risks related to whether the Company’s products will demonstrate safety and efficacy, risks related to the Company’s and Cognate’s abilities to carry out the intended manufacturing and expansions contemplated in the Cognate Agreements, risks related to the Company’s ability to carry out the Hospital Exemption program and risks related to possible reimbursement and pricing. Additional information on these and other factors, including Risk Factors, which could affect the Company’s results, is included in its Securities and Exchange Commission (“SEC”) filings. Finally, there may be other factors not mentioned above or included in the Company’s SEC filings that may cause actual results to differ materially from those projected in any forward-looking statement. You should not place undue reliance on any forward-looking statements. The Company assumes no obligation to update any forward-looking statements as a result of new information, future events or developments, except as required by securities laws.
Source: Northwest Biotherapeutics